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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
510(k) Number K874758
Device Name DANTEC 13L40 ST. MARKS'S PUDENDAL ELECTRODE
Applicant
DANTEC ELECTRONICS, INC.
6 PEARL COURT
ALLENDALE,  NJ  07401
Applicant Contact HENRIK HENRIKSEN
Correspondent
DANTEC ELECTRONICS, INC.
6 PEARL COURT
ALLENDALE,  NJ  07401
Correspondent Contact HENRIK HENRIKSEN
Regulation Number876.1620
Classification Product Code
FAP  
Date Received11/18/1987
Decision Date 04/14/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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